Whole-body Vibration Training in Older People
GERIAPLAT
Neuromuscular Training With Whole Body Vibration in Older People: A Randomized Multicentre Clinical Trial With Blinded to Evaluator
2 other identifiers
interventional
160
1 country
10
Brief Summary
This is a randomized, multicentre, and parallel clinical trial with blinded to evaluator. The principal hypothesis is that whole-body vibration training plus exercise improves the body balance and prevents falls more than only exercise training in institutionalized older people. The number needed of patients is 160 (80 per group).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2010
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 16, 2011
CompletedFirst Posted
Study publicly available on registry
June 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedAugust 29, 2012
August 1, 2012
10 months
June 16, 2011
August 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body balance.
Body balance will be evaluated using Tinetti Test, and Timed up and go test
at 6 weeks
Secondary Outcomes (4)
Body balance
at six months
Muscle performance
at 6 weeks, and 6 months
Number of falls
during 6 months
Safety of interventions
During 6 months
Study Arms (2)
Exercise with Whole-body vibration platform
EXPERIMENTALExercise with Whole-body vibration (WBV) platform (Power Plate®). The participants will perform static/dynamic exercises (balance and resistance training) on a vibratory platform (Frequency: 30-35 Hz; Amplitude: 2-4 mm). Training volume and intensity we will increase systematically over six weeks according to the overload principle.
Exercise
ACTIVE COMPARATORThe participants will perform the same static/dynamic exercises (balance and resistance training) like WBV group but without the vibration stimuli, during a six weeks training period (3sessions/week). Training volume and intensity we will increase systematically over six weeks according to the overload principle
Interventions
The participants will perform static/dynamic exercises (balance and resistance training) on a vibratory platform (Frequency: 30-35 Hz; Amplitude: 2-4 mm).
The participants will perform the same static/dynamic exercises (balance and resistance training) like WBV group but without the vibration stimuli.
Eligibility Criteria
You may qualify if:
- Institutionalized older people who were 65 years and older
- The patient consent to participate in the study
You may not qualify if:
- Residents who present an acute disease that not resolved during 10 days.
- Residents with a pacemaker (or serious cardiac alterations)
- Residents with epilepsy
- Residents with a high risk of thromboembolism
- Residents with a history of a hip or knee joint replacement
- Residents who not were musculoskeletal disorders and cognitive or physical dysfunction that interfering with test and training procedures.
- Residents that not accept to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Albada Centre Socio Sanitari Parc Taulí
Sabadell, Babadell, 08208, Spain
Ballesol Badalona
Badalona, Barcelona, 08911, Spain
Ballesol Barberà
Barbera Del Valles, Barcelona, 08210, Spain
Residència Poble Nou
Barcelona, Barcelona, 08005, Spain
Ballesol Fabra i Puig
Barcelona, Barcelona, 08016, Spain
Ballesol Almogàvers
Barcelona, Barcelona, 08018, Spain
Residència Mapfre Quavitae
Barcelona, Barcelona, 08025, Spain
Residència AMMA Horta
Barcelona, Barcelona, 08035, Spain
Residència Collserola (Mutuam)
Barcelona, Barcelona, 08035, Spain
Residència Allegra
Sabadell, Barcelona, 08203, Spain
Related Publications (2)
Sitja-Rabert M, Martinez-Zapata MJ, Fort Vanmeerhaeghe A, Rey Abella F, Romero-Rodriguez D, Bonfill X. Effects of a whole body vibration (WBV) exercise intervention for institutionalized older people: a randomized, multicentre, parallel, clinical trial. J Am Med Dir Assoc. 2015 Feb;16(2):125-31. doi: 10.1016/j.jamda.2014.07.018. Epub 2014 Oct 3.
PMID: 25282631DERIVEDSitja-Rabert M, Martinez-Zapata MJ, Fort-Vanmeerhaeghe A, Rey-Abella F, Romero-Rodriguez D, Bonfill X. Whole body vibration for older persons: an open randomized, multicentre, parallel, clinical trial. BMC Geriatr. 2011 Dec 22;11:89. doi: 10.1186/1471-2318-11-89.
PMID: 22192313DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mercè Sitjà Rabert, PhD
• Health Sciences Faculty Blanquerna (Universitat Ramon Llull)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2011
First Posted
June 17, 2011
Study Start
November 1, 2010
Primary Completion
September 1, 2011
Study Completion
March 1, 2012
Last Updated
August 29, 2012
Record last verified: 2012-08